Panels › Hematology › Product code GHM · Class 2
Test, Sickle Cell
Regulation 864.7825
0510(k)s in 12 months (18 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in GHM
| Company | 510(k)s | Recalls |
|---|---|---|
| Michclone Associates, Inc. | 2 | 3 |
| Isolab, Inc. | 4 | 0 |
| Anco Medical Reagents & Assoc. | 2 | 0 |
| Pacific Hemostasis | 2 | 0 |
| Streck Laboratories, Inc. | 2 | 0 |
| Chembio Diagnostic System Inc | 0 | 1 |
| Clinical Technology Corp. | 1 | 0 |
| Fisher Diagnostic, A Company of Fisher Scientific LLC | 0 | 1 |
| Livonia Diagnostics, Inc. | 1 | 0 |
| Panmed, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2012 | MichClone Associates, Inc. Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powde Terminated |
GHM | K860812 |
| May 9, 2012 | MichClone Associates, Inc. BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet Terminated |
GHM | K860812 |
| May 9, 2012 | MichClone Associates, Inc. Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powd Terminated |
GHM | K860812 |
| Feb 4, 2006 | Chembio Diagnostic System Inc Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Con Terminated |
GHM | K841272 |
| Sep 30, 2004 | Fisher Diagnostic, A Company of Fisher Scientific LLC Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations. Terminated |
GHM | K854079 |
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